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JAMA. 2001;286:2085.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved InSync Biventricular Cardiac Pacing System (Medtronic Inc, Minneapolis) for reduction of symptoms of moderate-to-severe heart failure in patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction of 35% or less and QRS duration of 130 milliseconds or more. In addition to one channel for atrial pacing and sensing, the device has two channels for simultaneous biventricular pacing and sensing from two ventricular leads. The device is noninvasively programmable and has activity-based responsive pacing capabilities.

The device was approved on the basis of studies in 579 patients with moderate-to-severe congestive heart failure at 39 centers in the United States and five in Canada. Of 532 patients in whom the InSync system was successfully implanted, 263 were randomized to receive the cardiac resynchronization treatment and 269 to a control group whose devices were not turned on.

During the 3-month and 6-month . . . [Full Text of this Article]

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